Amylin Pharmaceuticals Initiates Phase 2B Dose-Ranging Clinical Study of Pramlintide/Metreleptin Combination Treatment ...(oncentrations. Pramlintide is theactive ...),Health

Date:5/5/2008

oncentrations. Pramlintide is the active ingredient in SYMLIN(R) (pramlintide acetate) injection, which is indicated for use by patients with type 1 and type 2 diabetes who use mealtime insulin. Since launch, over 80,000 patients have been exposed to SYMLIN. To date, more than 6,000 individuals have received pramlintide in clinical trials, including more than 800 in obesity studies. In previous clinical studies, obese subjects treated with pramlintide 360 micrograms twice daily for 1 year experienced an average weight loss of approximately 8 percent from baseline compared with a 1 percent weight loss in patients receiving placebo. The most common side effect observed with pramlintide treatment in previous obesity studies was mild, transient nausea.

Metreleptin (methionyl recombinant leptin; r-metHuLeptin) is an analog of human leptin, a neurohormone secreted by fat cells that plays a fundamental role in the regulation of energy metabolism and body weight. Amylin acquired exclusive rights to the leptin molecular franchise and clinical program in 2006. To date, more than 1,000 individuals have received metreleptin in clinical trials, several hundred of which were obese and treated for 16 weeks or more. In multiple previous human clinical trials with metreleptin treatment alone, minimal weight loss was observed. This observation is consistent with findings in diet-induced obese rats, and suggests the presence of leptin resistance. In contrast, and consistent with findings in ob/ob (leptin deficient) mice, long-term treatment with metreleptin has been shown to elicit profound, fat-specific weight loss in severely obese individuals who are rendered leptin deficient by rare genetic mutations of the leptin gene. The most common side effect observed with metreleptin treatment in previous obesity studies was injection site adverse events.

About Amylin Pharmaceuticals

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SOURCE Amylin Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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